Automated synthesis systems are growing in importance for the production of radiopharmaceuticals. Synthesis systems, such as the FASTlab® system, sold by GE Healthcare of Liege, Belgium, provide for small-scale production of doses for clinical applications. The FASTlab synthesizer accepts and operates a cassette thereon for producing a radiopharmaceutical such as 18F-FLT ([18F]fluorothymidine), 18F-FDDNP (2-(1-{6-[(2-[18F]fluoroethyl)(methyl)amino]2-naphthyl}ethylidene)malonitrile), 18F-FHBG (9-[4-[18F]fluoro-3-(hydroxymethyl)butyl]guanine or [18F]-penciclovir), 18F-FESP ([18F]-fluoroethylspiperone), 18F-p-MPPF (4-(2-methoxyphenyl)-1-[2-(N-2-pyridinyl)-p-[18p]fluorobenzamido]ethylpiperazine) and 18F-FDG ([18F]-2-deoxy-2-fluoro-D-glucose) and the like.
The cassette typically includes a reaction vessel, a distillation vessel, reagent vials, cartridges, filters, syringes, tubings, and connectors for synthesizing a particular radiotracer. Different radiopharmaceuticals are made using cassettes customized for that radiopharmaceutical. The synthesis device, onto which the cassette is mounted, is configured to cooperatively engage the cassette so as to be able to actuate each of the stopcocks and syringes to drive a source fluid with a radioisotope through the cassette for performance of a chemical synthesis process. Additionally, the synthesis device includes a heating cavity which receives the first reaction vessel of the cassette therein so as provide the heat required for chemical reactions occurring therein.
The synthesizer is programmed to operate pumps, syringes, valves, the heating element, as well as controlling the provision of a motive gas (e.g., nitrogen) and the application of vacuum to the cassette so as to direct the source fluid into mixing with the reagents, performing the chemical reactions, through the appropriate purification cartridges, and selectively pumping the output tracer and waste fluids into appropriate vial receptacles, which are outside the cassette. While the fluid collected in the output vial is typically input into another system for either purification and/or dispensement, the synthesizer and cassette can also be connected to a separate purification system which returns a purified compound back to the cassette for further processing.
While quality control tests can determine whether a synthesized radiotracer product is suitable for use, the failure of a product to pass its quality review can be indicative of a problem in either the cassette or the synthesizer. As synthesizers, such as FASTlab, become more widely-used for the production of radiotracer products, there is a need in the art for a diagnostic device which can monitor synthesizer performance so as to detect any components of the synthesizer which are not performing to specifications or set standards.